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Low-Dose Naltrexone (LDN) for Depression Relapse and Recurrence

NCT01874951 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2017-02-24

Study results available
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Summary

The purpose of this pilot study is to determine if taking a low dose of naltrexone in addition to an antidepressant medication can help treat relapse or recurrence in people with Major Depressive Disorder (MDD). The U.S. Food and Drug Administration (FDA) has approved naltrexone for the treatment of alcohol dependence and opioid dependence, but the FDA has not approved naltrexone to treat depression. The investigators hypothesize that patients with breakthrough depression on an antidepressant regimen containing a pro-dopaminergic agent assigned to treatment with low dose naltrexone will demonstrate higher rates of response compared to those patients taking placebo.

Conditions

Interventions

DRUG

Naltrexone

1 mg of naltrexone will be given twice daily to all patients assigned to active drug.

DRUG

Placebo

Placebo identical in appearance to naltrexone will be given twice daily to all patients assigned to placebo.

Sponsors & Collaborators

  • Boston Clinical Trials

    collaborator OTHER

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • David Mischoulon, M.D. · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01874951 on ClinicalTrials.gov